Opinion
Index No. 30506/18
03-04-2022
Gardenia CAMACHO, Plaintiff, v. Robert D. PINTAURO and Mace Avenue Medical, P.C., Defendants.
Plaintiff's Attorney, Keith Clarke, Esq., Meagher & Meagher, P.C., 111 Church Street, White Plains, New York 10601, (914)328-8844 Defendants’ Attorney, Peter R. Taglia, Esq., Dwyer & Taglia, Esqs., 111 John Street, Suite 620, New York, New York 10038, (212)227-6000
Plaintiff's Attorney, Keith Clarke, Esq., Meagher & Meagher, P.C., 111 Church Street, White Plains, New York 10601, (914)328-8844
Defendants’ Attorney, Peter R. Taglia, Esq., Dwyer & Taglia, Esqs., 111 John Street, Suite 620, New York, New York 10038, (212)227-6000
Joseph E. Capella, J.
The following papers numbered 1 to 4 read on this motion.
PAPERS /NUMBERED
NOTICE OF MOTION, AFFIDAVITS AND MEMO OF LAW 1 - 2
ANSWERING AFFIDAVITS AND EXHIBITS 3
REPLY AFFIDAVITS AND EXHIBITS 4
UPON THE FOREGOING CITED PAPERS, THIS MOTION IS DENIED AS FOLLOWS:
The instant complaint is one sounding in medical malpractice and lack of informed consent, whereby plaintiff alleges, in sum and substance, that defendant, Robert D. Pintauro, a physician licensed to practice in New York employed by defendant, Mace Avenue Medical, P.C., was negligent in diagnosing plaintiff with rheumatoid arthritis (RA) and prescribing methotrexate. Defendants now seek full or partial summary judgment ( CPLR 3212(b), (e) ), and/or an order pursuant to Frye v United States (293 F 1013 [DC Cir 1923] ), precluding any expert testimony regarding plaintiff's allegation that methotrexate caused her to suffer mononeuritis multiplex or any other form of peripheral neuropathy.
A brief review of the facts reveals that on June 2, 2017, plaintiff spoke with Dr. Pintauro over the phone, complaining of warmness in her legs. Based on this conversation and the results of an earlier blood test from May 31, 2017, which showed an elevated rheumatoid factor (RF) of 591 IU/mL, Dr. Pintauro diagnosed plaintiff with RA and prescribed 7.5 mg of methotrexate once a week for three weeks. Plaintiff testified that she developed pain and swelling in the following days, and presented herself to Montefiore Wakefield emergency department (ED) on June 12, where they found weakness of the right foot and diffuse numbness below the right knee. Methotrexate was discontinued, and an ED podiatrist's assessment was "symptoms possible from drug interaction." An ED internist assessed that plaintiff had "nerve palsy, likely at fibular head, doubt radiculopathy," and noted that "the clinical presentation of this patient would be extremely unusual for RA." Ensuing exams found, inter alia , acute onset of foot drop with mononeuritis multiplex picture. Plaintiff underwent physical therapy, and on June 18, was discharged. Over the next three years, plaintiff continued to treat at Montefiore Wakefield, yet no specific diagnosis was ever determined. For example, on April 23, 2020, a rheumatologist at Montefiore Wakefield noted: "I do not feel that she has RA or an inflammatory rheumatologic condition at this time ... I feel that she has a neurologic problem that involves the right lower extremity, for which no specific diagnosis has been determined."
As summary judgment relief is being sought, defendants must make a prima facie showing of an entitlement to same as a matter of law by tendering sufficient evidence to eliminate any material issues of fact. ( Alvarez v Prospect , 68 NY2d 320 [1986].) In other words, defendants must provide evidentiary proof in the form of expert opinions and/or factual evidence that establishes that they did not deviate from accepted standards of care and practice, or that any departure was not a proximate cause of the injuries alleged. ( Korszun v Winthrop , 172 AD3d 1343 [2nd Dept 2019].) If they do, then the burden shifts to plaintiff to produce evidentiary proof in admissible form sufficient to create issues of fact to warrant a trial ( Alvarez , 68 NY2d 320 ), and denial of summary judgment.
According to defendants, they are entitled to summary judgment because 7.5 mg of methotrexate did not cause the alleged foot drop due to mononeuritis multiplex. In support of this argument, defendants provide an expert affirmation by Dr. Richard Crane, who is board certified in internal medicine with a sub-specialty certification in rheumatology. Dr. Crane opines that plaintiff taking 7.5 mg of methotrexate played no role in her development of a right foot drop. According to Dr. Crane, this medication in any dose or duration of use has never been known to cause a peripheral neuropathy, "cannot cause any adverse reaction or interaction (let alone a foot drop), the reaction occurred too soon since it happened a day or so after plaintiff's use of the medication, and drug-induced neurophathies invariably resolve within weeks after discontinuance." Dr. Crane notes that the treating physicians at Montefiore Wakefield did not find the cause of plaintiff's foot drop. He states that methotrexate is not a possible cause of plaintiff's foot drop, but there are several other possibilities, which include sarcoidosis, thyroid disease and spinal pathology.
Dr. Crane states that he reviewed medical literature (although he does not specify which one(s)), case reports and the drug information for methotrexate, and could not find any evidence that it has ever been implicated as a cause of a peripheral neuropathy. He did a search of methotrexate's interaction with plaintiff's other medication, and found no evidence that they caused a neuropathy. Dr. Crane states that the "interaction of methotrexate and Theophylline has been said in rare cases to cause a CNS (central nervous system), stroke-like syndrome, due to neurotoxicity, but this applies to high dose, intrathecal administration (injection into the dura or spinal space) in cancer patients." However, he goes on to state that this "has no bearing on the potential for 5.0 or 7.5 mg of oral methotrexate to cause a peripheral neuropathy." And "[e]ven with the many side effects that low dose methotrexate is known to cause, such as rashes, GI issues, liver and kidney dystunction, and hair loss, it has never been known to do so after one dose. The literature also indicates that drug-induced neuropathies generally resolve upon discontinuance of the offending drug." According to defendants, it is this lack of a causal link between methotrexate and plaintiff's injuries that they believe they are entitled to summary judgment. Alternatively, defendants argue that as there is no medical or scientific evidence demonstrating that low dose methotrexate can cause the alleged injury (foot drop due to mononeuritis multiplex ), plaintiff should be precluded from calling an expert to testify as to causation, or at the very least a hearing should be held as to whether this theory has the required level of support.
Addressing summary judgment first, given the aforementioned expert testimony by Dr. Crane, the Court is satisfied that defendants have met their burden for summary judgment, ( Zuckerman v City of NY , 49 NY2d 557 [1980] ; Kaffka v NY Hospital , 228 AD2d 332 [1st Dept 1996] ), which now shifts to plaintiff to demonstrate that issues of fact exist to warrant a trial. In opposition, plaintiff provides an expert affirmation from a physician who is board certified in internal medicine. According to plaintiff's expert, he reviewed an array of medical/scientific literature concerning RA, methotrexate (and its side effects), the administration of methotrexate when used in low doses, other type of inflammatory diseases, foot drop, peripheral neuropathies, mononeuritis multiplex, adverse reactions from topical steriods, and other conditions associated with the loss of sensory function in the lower extremities. He found literature confirming that neuropathies are a known side effect of methotrexatte, even when administered in low doses. He annexed a 2004 study conducted by the Department of Immunology-Rheumatology, Kasturba Medical College, demonstrating that methotrexate use can be causally related to the development of a peripheral neuropathy. He noted that in those cases, diagnostic testing on patients developing a peripheral neuropathy failed to rule out methotrexate as an inhibitor. He also included several other articles, including (1) Peripheral neuropathies from chemotherapeutics and targeted agents: diagnosis, treatment and prevention , (2) What is Peripheral Neuropathy , (3) Methotrexate Side Effects , (4) Rheumatoid Arthritis — Treatment , and (5) Teva Pharmaceuticals USA, Inc., Methotrexate Tablets , to confirm that, though rare, there is a known association between methotrexate use and peripheral neuropathies.
The name of plaintiff's expert is redacted. (CPLR § 3101(d)(1)(i) : Rivera v Albany , 119 AD3d 1135 [3rd Dept 2014].)
Plaintiff's expert also states that various comorbidities can contribute to the onset or exacerbation of peripheral neuropathy, and when combined with an antibiotic trimethoprim (e.g., Bactrim ), which plaintiff had previously taken, methotrexate has been confirmed to increase its level of toxicity by blocking renal excretion. He notes that the FDA's guidance and warnings on methotrexate use states that due to an increased risk of serious toxic effect, "methotrexate should only be used ... in patients with ... [RA] with severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy." He opines with a reasonable degree of medical certainty that the doses of methotrexate prescribed by Dr. Pintauro caused serious and permanent side effects to plaintiff, namely exacerbating a transient neuropathy. Additionally, in reviewing the medical records, plaintiff's expert could not find any criteria or symptoms (swelling, redness, and/or warmth in three or more joints for a prolonged period of time [six or more weeks] in conjunction with a positive CCP test) needed for an RA diagnosis, and it is his opinion that Dr. Pintauro deviated from the accepted standard of care when he diagnosed plaintiff with RA. He opines that Dr. Pintauro further deviated from the standard of care when he prescribed methotrexate after a brief phone call with plaintiff without further evaluation or consultation. Lastly, he opines that the misdiagnosed treatment of RA (i.e., Dr. Pintauro prescribing methotrexate to plaintiff) caused her transient neuropathy to become a permanent neuropathy. Viewing the evidence in a light most favorable to plaintiff, ( O'Sullivan v Presbyterian , 217 AD2d 98 [1st Dept 1995] ), the Court is satisfied that plaintiff has met her burden of producing evidentiary proof in admissible form sufficient to create issues of fact to warrant a trial ( Alvarez , 68 NY2d 320 ), and denial of summary judgment.
There still remains defendants’ request for an order pursuant to Frye v United States (293 F 1013 [DC Cir 1923] ), precluding any expert testimony regarding plaintiff's allegation that methotrexate caused her to suffer mononeuritis multiplex or any other form of peripheral neuropathy. The prevailing standard of care governing the conduct of medical professionals demands that doctors exercise a reasonable degree of learning and skill that is ordinarily possessed by physicians and surgeons in the locality where they practice. ( Pike v Hosinger , 155 NY 201 [1898].) They are charged with the duty to exercise due care, which is measured against the conduct of their peers (i.e., the reasonably prudent doctor standard), and implicit in this concept is the principle that doctors must employ their best judgment in exercising their skill and knowledge. ( Nestorowich v Ricotta , 97 NY2d 393 [2002].) Within the context of a medical malpractice action, as with any negligence action, plaintiff must establish that defendants’ negligence, which in this case is the alleged departure from good and accepted medical practice, proximately caused the injury claimed. ( Mortensen v Memorial Hospital , 105 AD2d 151 [1984].) Here the court is called upon to address the defendants’ challenge to plaintiff's allegation regarding causation. Specifically, plaintiff's allegation that methotrexate caused her to suffer mononeuritis multiplex or any other form of peripheral neuropathy does not constitute a generally accepted theory in the medical community. Under the test enunciated in Frye , which is the standard applied in New York courts, a proponent of novel science must establish its general acceptance among scientists within the relevant discipline to justify its admission. ( 293 F 1013 ; People v Angelo , 88 NY2d 217 [1996].) This test ensures that courts do not rely upon an expert's testimony regarding a novel theory or procedure unless it has been generally accepted within the relevant scientific community as leading to reliable results, and essentially distinguishes between principles which are "demonstrable" versus "experimental."
As previously mentioned, the test enunciated in Frye requires the proponent of novel science to establish its general acceptance among scientists within the relevant discipline to justify its admission. ( 293 F 1013 ; Angelo , 88 NY2d 217.) But as noted by Justice Saxe, since Frye entails a process of weighing the views of each side's experts, some trial courts are erroneously tempted to weigh the relative merits of each expert's testimony to determine reliability; however, the court's function is not to decide which expert's conclusion is correct. ( Marsh v Smyth , 12 AD3d 307 [1st Dept 2004].) Competing expert theories as to causation or the mechanism of an injury do not warrant a Frye hearing, but entails a weighing of the evidence that falls within the domain of the jury. ( Barnett, 85 AD3d 832 ; Frye , 70 AD3d 15.) To hold a hearing in this context would simply provide the defendants with an extra opportunity to cross-examine plaintiff's expert and pinpoint perceived weaknesses ( Marsh , 12 AD3d 307 ).
Defendants are the party seeking a Frye hearing, and as such, they bear the initial burden of showing that there is a question as to whether an expert's methodologies or deductions are based upon principles that are sufficiently established to have gained acceptance as reliable. ( People v Oddone , 89 AD3d 868 [2nd Dept 2011.) An appropriate Frye challenge exists when the expert's theory of causation finds no objective support, and instead is based solely on the expert's own unsupported beliefs. And the limited question to address at a Frye hearing is whether the expert's opinion properly relates existing data, studies or literature to plaintiff's situation, or whether it is connected to existing data only by the ipse dixit of the expert. ( General Electric v Joiner , 522 US 136 [1997].) Also keep in mind that general acceptance does not necessarily mean that the majority of scientists subscribe to the conclusion. ( Zito v Zabarsky , 28 AD3d 42 [2nd Dept 2006].) Instead it means that those espousing the theory or opinion have followed generally accepted scientific principles and methodology in evaluating clinical data to reach their conclusions. (Id. ) Where there is no novel test or technique involved, and the proposed testimony involves a novel theory of causation, where such opinion is supported by generally accepted scientific methods, then you proceed to the foundational inquiry of admissibility, which is whether the theory is founded on generally accepted scientific methods or principles. ( Parker v Mobil , 7 NY3d 434 [2006] ; Ratner v McNeil , 91 AD3d 63 [2nd Dept 2011] ; Zito , 28 AD3d 42.) For example, the plaintiff in Parker alleged that his exposure to benzene in gasoline caused him to develop leukemia. The Court of Appeals in Parker was called upon to address defendants’ motion to preclude the testimony of plaintiff's expert pursuant to Frye , because said testimony did not, inter alia , quantify the benzene exposure, and was therefore scientifically unreliable. The Court of Appeals found that it was not always necessary for a plaintiff to quantify exposure levels precisely, provided that whatever methods an expert uses to establish causation are generally accepted in the scientific community. Thus, the inquiry was more akin to whether there was an appropriate foundation for the expert's opinion, rather than whether the opinion is admissible under Frye .
In Ratner , defendants sought to preclude plaintiff's expert from testifying as to a causal connection between the therapeutic use of acetaminophen, and a subsequent development of liver cirrhosis. ( 91 AD3d 63.) The parties did not dispute that acetaminophen is toxic to the liver in overdose, and in cases of massive overdose, acetaminophen can cause acute liver failure. However, defendants argued that the opinion of plaintiff's expert that long-term acetaminophen use at therapeutic doses can cause cirrhosis, was not generally accepted in the medical and scientific community. The Second Department found that plaintiff's expert was not utilizing any novel scientific technique or evidence — rather, said expert sought to set forth the novel theory that therapeutic acetaminophen use caused the plaintiff's liver cirrhosis primarily based upon the fact that acetaminophen is a hepatotoxin and that certain case studies suggest a relationship between acetaminophen and cirrhosis. The Court then held that when an expert seeks to introduce a novel theory of medical causation without relying on a novel test or technique, the proper inquiry begins with whether the opinion is properly founded on generally accepted methodology, rather than whether the causal theory is generally accepted in the relevant scientific community. And in Zito , the Second Department held that "while it is conceded that the plaintiff's expert did not produce medical literature which expressly supported their view that an excessive dose of Zocor caused the plaintiff to develop polymyositis, they supported their theory of a causal nexus between an excessive dose of Zocor and polymyositis with generally accepted scientific principles and existing data" ( 28 AD3d at 45 ).
Here each expert relies upon the medical records to render an opinion. Plaintiff's expert opines that the doses of methotrexate prescribed by Dr. Pintauro caused serious and permanent side effects to plaintiff, namely exacerbating a transient neuropathy. Defendants’ expert opines that methotrexate is not a possible cause of plaintiff's foot drop, but there are several other possibilities, which include sarcoidosis, thyroid disease and spinal pathology. In other words, plaintiff's expert is relying on certain facts in the medical records to suggest one theory, and defendants’ expert relying on certain other facts to suggest another theory. The end result being two experts asserting diametrically opposed positions, each relying on scientific literature to support their claims ( People v Wesley , 83 NY2d 417 [1994] ), and a factual disagreement as to causation. ( Lustenring v AC & S , 13 AD3d 69 [1st Dept 2004].) This in fact engenders a weighing of the evidence, which is outside the scope of this Court's function in performing a Frye analysis.
To the extent that defendants may also be suggesting that the opinion by plaintiff's expert is somehow conclusory, unsubstantiated or unsupported by evidence in the medical record, this too would not warrant a Frye hearing. (Krackmalnick v Maimonides , 142 AD3d 1143[2nd Dept 2016].)
As for the more specific suggestion by defendants that plaintiff's theory as to causation (i.e., that methotrexate caused plaintiffs’ peripheral neuropathy ) is a novel one under Frye , defendants did not meet their burden of showing that this deduction is somehow experimental. ( People v Oddone , 89 AD3d 868 [2nd Dept 2011.) Defendants’ expert did not specify what medical literature he reviewed to render his opinion as to causation, and his conclusion that he could not find any evidence that methotrexate has ever been implicated as a cause of a peripheral neuropathy was rebutted by plaintiff's expert citation to specific literature confirming that neuropathies are a known side effect of methotrexatte. As Justice Saxe noted in March v Smyth , it is not necessary "that the underlying support for the theory of causation consist of cases or studies considering circumstances exactly parallel to those under consideration in the litigation. It is sufficient if a synthesis of various studies or cases reasonably permits the conclusion reached by the plaintiff's expert." ( 12 AD3d 307.) What we have here are parties that have come forward with experts who disagree on material issues of fact regarding whether there was a departure and proximate cause ( Alvarez , 68 NY2d 320 ) — issues that must be resolved by the trier of fact. ( Barnett v Fashakin, 85 AD3d 832 [2nd Dept 2011] ; Frye v Montefiore , 70 AD3d 15 [1st Dept 2009] ). The trier of fact will hear from these experts, including the evidence that each one relies upon in forming the basis for their expert opinion, and in turn they will evaluate the weight and credibility of the testimony of these experts. ( Cassano v Hagstrom , 5 NY2d 643 [1959] ; State v Marks , 87 AD3d 73 [3rd Dept 2011].) Therefore, defendants’ motion is denied, and plaintiff is directed to serve a copy of this decision with notice of entry by first class mail upon defendants within 30 days of receipt of copy of same. This constitutes the decision and order of this court.